Tharanya Ramesh

About Tharanya Ramesh

Experienced Clinical Research Professional with over 4 years of expertise in trial management, TMF operations, and regulatory compliance. I specialize in eTMF setup, audit readiness, vendor oversight, and risk mitigation, ensuring smooth and compliant execution of global clinical trials.Currently working as a Project Operations Analyst (Assistant PM) at ICON, I collaborate with cross-functional teams, sponsors, and vendors to drive project execution, document quality control, and risk management. My experience spans across ICH-GCP guidelines, CAPA execution, regulatory audits, and stakeholder communication, making me adept at handling clinical trial documentation and milestone tracking.Key Expertise: Clinical Trial Management & TMF Operations Regulatory Compliance (ICH-GCP, FDA, MHRA) Vendor Oversight & Stakeholder Collaboration Audit Readiness & Quality Control Project & Risk Management in Clinical Trials Training & Mentoring Teams on TMF Best PracticesPassionate about improving trial documentation processes and ensuring compliance, I am eager to contribute my expertise to organizations focused on clinical research excellence. Let’s connect and collaborate!

Experience

1. Project Operations Analyst 1 (Assistant Pm)

   ICON plc

   Jul 2024 — Present · Chennai, IN

   Collaborate with project teams, internal/external clients, clinical/scientific teams, and vendors for successful project execution.2. Identify project risks, implement mitigation strategies, and lead meetings, issue resolution, project recaps, and CAPA execution.3. Manage project scope, financial tracking, vendor invoices, and ensure timely contract and change order execution.4. Conduct eTMF QC/QR activities, review TMF for inspection readiness, and submit review checklists.5. Support recruitment forecast setup, maintenance, and updates in PM Study Milestone Tracker.6. Assist PM in developing study plans, including communication, recruitment/retention, training plans, and training matrices.7. Monitor Operational Data Quality Application (ODQA) queries and ensure operational data accuracy and compliance.8. Manage Manual Traffic Light Report (TLR) for Source Data Verification (SDV) standard and additional SDV tracking.9. Oversee vendor management, including governance, performance assessments, issue resolution, and CAPA implementation.10. Develop and maintain project schedules with MSP, identifying and mitigating milestone risks.11. Create and update reports for recruitment baseline, SDV forecasting, and study optimizer scenarios.12. Maintain Out-of-Scope (OOS) and Change Order (CO) logs, tracking project scope changes.13. Lead financial and resource tracking, ensuring timely purchase orders and budget alignment.14. Provide training to CTMs and PMs on iRecruit and other project-specific systems.15. Contribute to internal initiatives, system enhancements, and strategic process improvements.

Education

• R G Matriculation Higher Secondary School

  High School, Bio-Maths

• R G Matriculation Higher Secondary School

  SSLC

• Bharathidasan University, Tiruchirappalli

  Bachelor of Technology - BTech, Biotechnology